2.Reporting Results of Research Involving Human Subjects: An Ethical Obligation.
Allison Baer ALLEY ; Jeong Wook SEO ; Sung Tae HONG
Journal of Korean Medical Science 2015;30(6):673-675
Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.
Clinical Trials as Topic/*ethics
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*Ethics, Research
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Human Experimentation/*ethics
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Publishing/*ethics
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Republic of Korea
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*Research Report
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Research Subjects
3.Ethical Considerations in Hospice and Palliative Care Research
Korean Journal of Hospice and Palliative Care 2019;22(2):49-66
Along with the advances in medical technology and the economic development, more terminally ill patients are receiving hospice and palliative care services. Moreover, hospice and palliative care clinicians have been showing considerable interest in studies that aim to improve the quality of said care for patients and their families. Meanwhile, after the government has strengthened its policy to protect research participants, the institutional review boards (IRBs) are more closely examining various ethical issues related to patients' vulnerability when reviewing protocols for hospice and palliative care research. However, terminally ill patients should be provided with guaranteed qualities of hospice and palliative care to improve and maintain their quality of life. To that end, support should be provided for efforts to conduct ethical and safe studies with hospice and palliative care patients. Thus, this review paper proposes ethical guidelines for hospice and palliative care research. The guidelines could be appropriately used as a reference for researchers who should prepare for ethically safe and scientifically valued research protocols and the IRBs that will review the protocols.
Economic Development
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Ethics
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Ethics Committees, Research
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Hospice Care
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Hospices
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Human Experimentation
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Humans
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Palliative Care
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Patient Rights
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Quality of Life
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Terminally Ill
4.Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance.
Jing-Ru LI ; Simon WALKER ; Jing-Bao NIE ; Xin-Qing ZHANG
Journal of Zhejiang University. Science. B 2019;20(1):32-38
The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus (HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE's genetic experiments. China's guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE's human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist's self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.
CRISPR-Cas Systems
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China
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Consent Forms/ethics*
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Ethics, Medical
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Female
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Gene Editing/legislation & jurisprudence*
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Gene Knockout Techniques/ethics*
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HIV Infections/prevention & control*
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Human Experimentation/legislation & jurisprudence*
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Humans
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Infant, Newborn
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Pregnancy
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Professional Misconduct/ethics*
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Receptors, CCR5/genetics*
5.Current Status of the Institutional Review Boards in Korea: Constitution, Operation, and Policy for Protection of Human Research Participants.
Ock Joo KIM ; Byung Joo PARK ; Dong Ryul SOHN ; Seung Mi LEE ; Sang Goo SHIN
Journal of Korean Medical Science 2003;18(1):3-10
The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.
Appointments and Schedules
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Clinical Trials/legislation & jurisprudence
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Clinical Trials/standards
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Data Collection
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Epidemiologic Studies
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Ethics Committees, Research*/legislation & jurisprudence
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Ethics Committees, Research*/standards
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Ethics Committees, Research*/statistics & numerical data
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Female
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Human
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Human Experimentation/legislation & jurisprudence
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Human Experimentation/standards
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Korea
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Male
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Politics
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Public Policy
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Research Design/standards
6.Experiment at Bedside: Harvey Cushing's Neurophysiological Research.
Korean Journal of Medical History 2009;18(2):205-222
No abstract in English.
History, 19th Century
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History, 20th Century
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Humans
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Neuralgia/history/surgery
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Neurophysiology/*history
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Neurosurgery/*history
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Therapeutic Human Experimentation/ethics/*history
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United States